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Ciprofloxacin resistant

ciprofloxacin resistant

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Generic name: CIPROFLOXACIN HYDROCHLORIDE 250mg
Dosage form: tablet, film coated

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The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

CIPRO Tablets and Oral Suspension should be administered orally as described in the appropriate Dosage Guidelines tables.

Dosage in Adults

The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal ciprofloxacin and hepatic function. CIPRO Tablets or Oral Suspension may be administered to adult patients when clinically indicated at the discretion of the physician. Administer CIPRO for Oral Suspension using the co-packaged graduated spoon [see Dosage and Administration (2.7)].

Table 1: Adult Dosage Guidelines
Infection Dose Frequency Usual Durations
Skin and Skin Structure 500–750 mg every 12 hours 7 to 14 days
Bone and Joint 500–750 mg every 12 hours 4 to 8 weeks
Complicated Intra–Abdominal 500 mg every 12 hours 7 to 14 days
Infectious Diarrhea 500 mg every 12 hours 5 to 7 days
Typhoid Fever 500 mg every 12 hours 10 days
Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose
Inhalational anthrax (post-exposure) 500 mg every 12 hours 60 days

4 to 8 weeks

Plague 3 500–750 mg every 12 hours 14 days
Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days
Lower Respiratory Tract Infections 500–750 mg every 12 hours 7 to 14 days
Urinary Tract Infections 250–500 mg every 12 hours 7 to 14 days
Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days
Acute Sinusitis 500 mg every 12 hours 10 days

Conversion of IV to Oral Dosing in Adults

Patients whose therapy is started with CIPRO IV may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].

Table 2: Equivalent AUC Dosing Regimens

CIPRO Oral Dosage

Equivalent CIPRO IV Dosage

250 mg Tablet every 12 hours

200 mg intravenous every 12 hours

500 mg Tablet every 12 hours

400 mg intravenous every 12 hours

750 mg Tablet every 12 hours

400 mg intravenous every 8 hours

Dosage in Pediatric Patients

Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. CIPRO should be administered as described in Table 3. Administer CIPRO for Oral Suspension using the co-packaged graduated spoon [see Dosage and Administration (2.7)].

Table 3: Pediatric Dosage Guidelines Infection Dose Frequency Total Duration

Complicated Urinary Tract or Pyelonephritis

(patients from 1 to 17 years of age)

10 mg/kg to 20 mg/kg

(maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)

Every 12 hours

10–21 days

Inhalational Anthrax (Post-Exposure)2

15 mg/kg

(maximum 500 mg per dose)

Every 12 hours

60 days

Plague2,3

15 mg/kg

(maximum 500 mg per dose)

Every 8 to 12 hours

10–21 days

Dosage Modifications in Patients with Renal Impairment

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.

Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function

Creatinine Clearance (mL/min)

Dose

> 50

See Usual Dosage.

30–50

250–500 mg every12 hours

5–29

250–500 mg every 18 hours

Patients on hemodialysis or Peritoneal dialysis

250–500 mg every 24 hours (after dialysis)

When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:

Men - Creatinine clearance (mL/min) = Weight (kg) x (140–age)

72 x serum creatinine (mg/dL)

Women - 0.85 x the value calculated for men.

The serum creatinine should represent a steady state of renal function.

In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).

Important Administration Instructions

With Multivalent Cations

Administer CIPRO at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.

With Dairy Products

Concomitant administration of CIPRO with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, CIPRO may be taken with a meal that contains these products.

Hydration of Patients Receiving CIPRO

Assure adequate hydration of patients receiving CIPRO to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Instruct the patient of the appropriate CIPRO administration [see Patient Counseling Information (17)].

Directions for Reconstitution of the CIPRO Microcapsules for Oral Suspension

CIPRO Oral Suspension is supplied in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. CIPRO oral suspension is composed of two components (microcapsules and diluent) that must be combined prior to dispensing.

Table 5: Appropriate Dosing Volumes of the Reconstituted Oral Suspensions

Dose

5%

(250 mg/5 mL)

10%

(500 mg/5 mL)

250 mg

5 mL

2.5 mL

500 mg

10 mL

5 mL

750 mg

15 mL

7.5 mL

Preparation of the suspension:

Step1

Step 1

The small bottle contains the microcapsules, the large bottle contains the diluent.

Step 2

Step 2

Open both bottles. Child-proof cap: Press down according to instructions on the cap while turning to the left.

Step 3

Step 3

Pour the microcapsules completely into the larger bottle of diluent. Do not add water to the suspension.

Step 4

Step 4
1. Remove the top layer of the diluent bottle label (to reveal the CIPRO Oral Suspension label). Close the large bottle completely according to the directions on the cap and shake vigorously for about 15 seconds. The suspension is ready for use.

Step 5: Write the expiration date of the re-constituted oral suspension on the bottle label.

Reconstituted product may be stored below 30°C (86°F) for 14 days. Protect from freezing.

No additions should be made to the mixed final ciprofloxacin suspension. CIPRO Oral Suspension should not be administered through feeding or NG (nasogastric) tubes due to its physical characteristics.

Administration Instructions for CIPRO for Oral Suspension After Reconstitution

• Shake CIPRO Oral Suspension vigorously each time before use for approximately 15 seconds. • Administer CIPRO Oral Suspension using the co-packaged graduated teaspoon provided for the patient (see Figure 1)
gradated spoon

The Co-packaged graduated teaspoon (5mL) is provided, with markings for 1/2 (2.5 mL) and 1/1 (5 mL)

• After use, clean the graduated teaspoon under running water with dish detergent and dry thoroughly. • Do Not chew the microcapsules in the CIPRO Oral Suspension, instead swallow them whole. • Water may be taken afterwards. • Reclose the bottle properly after each use according to instructions on the cap.

After treatment has been completed, CIPRO Oral Suspension should not be reused.

Dosing of CIPRO for Oral Suspension using the Co-Packaged Spoon in Adults and Pediatric Patients

Table : 5% Cipro for Oral Suspension: 250 mg ciprofloxacin per 5 mL after reconstitution

Infection

Body weight (kg)

Dose by Measuring Spoonful(s) using Co-Packed Spoon
(teaspoonful (s) (volume (mL))

Dose Strength

(mg)

Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)1

and Plague2

9 kg to 12 kg

½ teaspoonful (2.5 mL)

125 mg

13 kg to 18 kg

1 teaspoonful (5 mL)

250 mg

19 kg to 24 kg

1 to 1 ½ teaspoonful(s) (5 mL to 7.5 mL)

250 mg̶̶ to 375 mg

25 kg to 31 kg

1 ½ to 2 teaspoonfuls (7.5 mL to 10 mL)

375 mg to 500 mg

32 kg to 37 kg

1 ½ to 2 ½ teaspoonfuls (7.5 mL to 12.5 mL)

375 mg to 625 mg

38 kg or more

2 to 3 teaspoonfuls (10 mL to 15 mL)

500 mg to 750 mg

Inhalational Anthrax (Post-Exposure)3

9 kg to 12 kg

½ teaspoonful (2.5 mL)

125 mg

13 kg to 18 kg

1 teaspoonful (5 mL)

250 mg

19 kg to 24 kg

1 to 1 ½ teaspoonful(s) (5 mL to 7.5 mL)

250 mg̶̶ to 375 mg

25 kg or more

2 teaspoonfuls (10 mL)

500 mg

A graduated teaspoon (5mL) with markings 1/2 (2.5) mL and 1/1 (5 mL) is provided for the patient.

1Administer every 12 hours for 10-21 days [see Dosage and Administration (2.2)]

2Administer every 8-12 hours for 10-21 days for Pediatric patients [see Dosage and Administration (2.2)]; for adults administer every 12 hours for 14 days [see Dosage and Administration (2.1)]

3Administer every 12 hours for 60 days [see Dosage and Administration (2.1 and 2.2)]

Table 7: 10% Oral Suspension: 500 mg ciprofloxacin per 5 mL after reconstitution (not appropriate for children weighing less than 13 kg)

Infection

Body weight (kg)

Dose by Measuring Spoonful(s) using Co-Packed Spoon (teaspoonful (s) (volume (mL))

Dose Strength

(mg)

Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)1

and Plague2

13 kg to 24 kg

½ teaspoonful (2.5 mL)

250 mg

25 kg

½ to 1 teaspoonful (2.5 mL to 5 mL)

250 mg to 500 mg

26 kg to 37 kg

1 teaspoonful (5 mL)

500 mg

38 kg or more

1 to 1½ teaspoonful(s) (5 mL to 7.5 mL)

500 mg to maximum dose of 750 mg

Inhalational Anthrax (Post-Exposure)3

13 kg to 24 kg

½ teaspoonful (2.5 mL)

250 mg

25 kg or more

1 teaspoonful (5 mL)

500 mg

A graduated teaspoon (5mL) with markings 1/2 (2.5) mL and 1/1 (5 mL) is provided for the patient.

1Administer every 12 hours for 10-21 days [see Dosage and Administration (2.2)]

2Administer every 8-12 hours for 10-21 days for Pediatric patients [see Dosage and Administration (2.2)]; for adults administer every 12 hours for 14 days [see Dosage and Administration (2.1)]

3Administer every 12 hours for 60 days [see Dosage and Administration (2.1 and 2.2)]

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